EASL 2025: SCG101 Phase I Trial Demonstrates Dual Efficacy in HBV Clearance and Tumor Regression

May 8, 2025, at the 2025 European Association for the Study of the Liver (EASL) Annual Meeting in Amsterdam, Netherlands（EASL2025）Above,SCG SCIENCE (DALIAN) CO., LTD HBV-Specific TCR-T Cell Therapy - SCG101 Achieves Another Breakthrough（Late-breaking）Clinical Research. The latest data from the clinical trial shows that SCG101 inTreatment of Advanced HBV-Related Hepatocellular Carcinoma（HCC）The patients exhibited remarkable antiviral and antitumor dual effects, drawing significant attention from the global hepatology and oncology communities.

According to the published content, all 17 patients achieved serum hepatitis B surface antigen clearance after receiving a single infusion of SCG101.（HBsAg）A rapid cliff-like decline was observed, with up to 94% of patients experiencing a reduction of 1.0–4.6 log₁₀ within 28 days. During the follow-up period of up to one year, patients' HBsAg levels remained consistently below 100 IU/mL. Notably, this included 4 patients.(Accounting for approximately 23.5%)Achieved complete clearance of HBsAg within 21 days after receiving treatment and maintained the clearance status throughout the follow-up period.

In addition to its breakthrough antiviral efficacy, SCG101 also demonstrated significant antitumor activity. All participants in the study were end-stage liver cancer patients who had already received existing standard systemic cancer treatments.(Including immune checkpoint inhibitor therapy)Failure, and lack of effective treatment options. After a single infusion of SCG101, up to 47% of patients achieved tumor regression. As of the data cutoff date, the median overall survival of the patients was...（OS）The median follow-up period has exceeded 10.6 months and is still ongoing. Compared with the current median OS of end-stage liver cancer patients, which generally does not exceed 6 months, this suggests that SCG101 therapy may offer long-term survival benefits for patients with advanced liver cancer.

Professor Du Shunda, Director of the Department of Hepatic Surgery at Peking Union Medical College HospitalIt was pointed out: "The dual antiviral and antitumor efficacy demonstrated by SCG101 in patients undergoing multiline therapy is highly encouraging. The sustained levels of hepatitis B surface antigen...（HBsAg）"The clearance and tumor remission not only confirm the effectiveness of this therapy but also imply that SCG101 has the potential to open up a new multidimensional immunotherapy pathway for patients with hepatitis B-related liver cancer, possibly addressing a significant long-standing clinical need in this field."

Hepatitis B remains a significant global public health challenge, threatening the health of more than 250 million people worldwide and being the leading cause of liver cancer. Chronic hepatitis B infection leads to the integration of HBV viral DNA into the host genome, causing continuous expression of HBsAg, disrupting chromosomal stability, activating oncogenes, and subsequently leading to the occurrence and development of hepatocellular carcinoma. ²Globally, 50%-80% of hepatocellular carcinoma cases are caused by HBV infection.¹China is a major country for liver cancer. Unlike in Europe and the United States, HBV infection is the leading cause of liver cancer in China.

Dr. Ke Zhang, Chief Scientific Officer of SCG SCIENCE (DALIAN) CO., LTDStates: "SCG101 identifies the major histocompatibility complex（MHC）The presented HBV-specific epitopes enable precise targeting and clearance of HBV-infected cells. With its unique immune mechanism, this therapy not only efficiently eliminates HBV-infected hepatocytes but also accurately targets and destroys precancerous lesion cells and hepatocellular carcinoma cells with HBV-DNA integration. By comprehensively blocking the pathological process of HBV-related liver cancer at key stages from viral infection to tumor development, it provides a novel therapeutic strategy for overcoming this difficult-to-treat disease. The data disclosed at this conference is not only an important milestone in the development of SCG101 but also demonstrates our unique potential and innovative value in the field of precision TCR-T cell therapy. As the world’s first cellular immunotherapy to achieve complete virological clearance and significant tumor regression in patients with HBV-related liver cancer, it brings new hope to patients in urgent need."

References:

[1] Y, Xie. (2017). Hepatitis B virus-associated hepatocellular carcinoma. Advances in experimental medicine and biology. 

[2] Jiang, Y., Han, Q., Zhao, H., Zhang, J. (2021, May 20). The mechanisms of HBV-induced hepatocellular carcinoma. Journal of hepatocellular carcinoma. 

[3] Liver cancer statistics: World cancer research fund international. WCRF International. (2022, April 14). 

[4] Golabi P, Fazel S, Otgonsuren M, Sayiner M, Locklear CT, Younossi ZM. (2017). Mortality assessment of patients with hepatocellular carcinoma according to underlying disease and treatment modalities.

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